Today’s manufacturers have plenty of software solution options that are meant to enhance their productivity. You may be familiar with each of these software packages. However, if you are not, it is important to understand what each of these software packages are designed to deliver.

Enterprise resource planning (ERP): ERP systems help you to focus on the business aspects of your manufacturing processes. This includes things like supply and demand, scheduling, actual costs, accounting, and more. In essence, ERP tracks the execution of the business aspects of manufacturing. But while an ERP system offers high-level tracking of many business operations, it may have gaps in specific functionality. These gaps are often filled by additional software like PLM, MES, or QMS.

Production life-cycle management (PLM): The PLM system was developed to help track processes and product innovation. As such, it focuses on design, development, and production planning. In other words, PLM focuses on the innovation of your product line.

The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)¹ which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.

Under section 120302 the legislation says specifically (emphasis is mine):

“(a) EMERGENCY TEMPORARY STANDARD

(1) In general—in consideration of the grave danger presented by COVID-19 and the need to strengthen protections for employees, notwithstanding the provisions of law and the Executive orders listed in paragraph (7), not later than 7 days after the date of enactment of this Act, the Secretary of Labor shall promulgate an emergency temporary standard to protect from occupational exposure to SARS-CoV-2—

(A) employees of health care sector employers;
(B) employees of employers in the paramedic and emergency medical services, including such services provided by firefighters and other emergency responders; and
(C) other employees at occupational risk of such exposure. ...

A new report from Trend Micro Research illustrates how advanced hackers are using unconventional attack vectors against smart manufacturing environments. Smart manufacturing technology generally operates through proprietary systems, which use their own proprietary language. However, these systems also still run on the computing power of traditional IT systems. While typically designed to function independently from other systems, it’s this particular loophole that leaves these systems vulnerable to IT threats.

“Past manufacturing cyberattacks have used traditional malware that can be stopped by regular network and endpoint protection,” says Bill Malik of Trend Micro. “However, advanced attackers are likely to develop operational technology-specific attacks designed to fly under the radar. As our research shows, there are multiple vectors now exposed to such threats, which could result in major financial and reputational damage for Industry 4.0 businesses. The answer is IIoT-specific security designed to root out sophisticated, targeted threats.”

Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.

But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating and deciding whether to approve new drugs and other products, has a problem. The FDA’s standards appear to be dropping at a time when rigorous regulatory review and robust oversight are crucial.

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of section 8 of the standard.

Clause 8: Operation

Clause 8 contains the requirements for planning, designing, and bringing to fruition your products or services. The processes within this clause must be robustly implemented to achieve business excellence. They must also be continually scrutinized for foreseeable risk.

8.1 Operational planning and control

8.1 and excellence
The “plan” is a series of interrelated process, each with acceptance criteria, and each with metrics that tie to the organization’s key objectives and key process indicators. Or, at least that has been my interpretation while leading scores of implementations.

For many manufacturing quality professionals, the thought of updating their statistical process control (SPC) solution is like getting an extra birthday. Many quality experts know that modernizing the way they collect, analyze, and use data is a critical need for their organizations, now more than ever.

But it may not be easy to convince the rest of the stakeholders in a company to not only approve a new quality intelligence solution but also adopt and use it. Fortunately, InfinityQS understands the challenge. We’ve been helping organizations through this process for three decades, and we’ve learned one fundamental principle for success: Start with a proof of concept.